Actively Recruiting

Phase Not Applicable
Age: 0Months - 9Months
All Genders
Healthy Volunteers
ID06479278

Talk With Me Baby to Enhance Early Home Language Environment During Well-Child Care Visits for Rural and Underserved Infants

Led by IDeA States Pediatric Clinical Trials Network · Updated on 2025-08-29

66

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

I

IDeA States Pediatric Clinical Trials Network

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating whether the Talk With Me Baby (TWMB) program can improve the home-language environment for families with infants aged two to six months, especially those at risk. The study focuses on whether this program, delivered during routine well-child visits, can increase the time caregivers spend talking to their infants. It aims to understand how enhancing caregiver-infant communication during early development impacts language and behavior in infants. The study involves embedding the TWMB program into standard well-child care visits. Participants will attend up to four consecutive well-child checkups within a 12-month period, during which primary care providers will deliver the TWMB language-promotion intervention alongside usual care. Caregivers will receive this program at each visit to support language development in their infants. During the study, caregivers will record their conversations with their infants before and after receiving the TWMB intervention across four sessions. Researchers will assess changes in language promotion behaviors using the Language Environment Analysis (LENA) system, focusing on conversational turn counts and adult word counts over a 12-month period. The involvement includes attending well-child visits, participating in the intervention, and completing language recordings to monitor progress and outcomes.

CONDITIONS

Brief Title

Talk With Me Baby to Enhance the Early Home Language Environment

Who Can Participate

Age: 0Months - 9Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Caregiver who will receive the Talk With Me Baby program during routine well-child care visits at participating clinics
  • Child receiving well-child care at a participating clinic
  • Caregiver is an adult as defined by their state of residency
  • Caregiver can complete study measures in English
  • Caregiver has legal authority to consent for themselves and their child
  • Caregiver-child dyad has a Language Environment Analysis baseline score at or below the 75th percentile
  • Child is zero to nine months old (+ 0-30 days) at enrollment
  • Child was born at full term (more than 37 weeks gestation)
  • Child was born as a singleton (only one baby delivered)
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 12 months

Participants receive the Talk With Me Baby language-promotion intervention embedded within up to 4 consecutive routine Well-Child Care visits over a 12-month period.

Up to 4 routine Well-Child Care visits

Trial Site Locations

Total: 2 locations

1

Kansas University Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

2

West Virginia University

Morgantown, West Virginia, United States, 26506

Not Yet Recruiting

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Research Team

S

Song Ounpraseuth, PhD

D

DeAnn E Hubberd, MA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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